Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial

N/ACompletedNCT01923831

Yonsei University146 enrolled

Overview

The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

146

Conditions

Post Operative Sore Throat

Interventions

Magnesium SulfateDRUG

Magnesium sulfate 30 mg kg-1 was infused in 100mL normal saline for 10 minutes immediately before anesthesia induction. After tracheal intubation, normal saline 1.6mL ( equivalent volume as Dexamethasone 8mg) was injected, and magnesium sulfate was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)

dexamethasoneDRUG

Normal saline 100mL was infused for 10 minutes immediately before anesthesia induction. After tracheal intubation, dexamethasone 8mg was injected, and normal saline was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation Exclusion Criteria: * preexisting hoarseness or sore throat, upper respiratory tract infection * steroid therapy or immunocompromised patients * chronic treatment with calcium channel blocker or magnesium * allergy to magnesium sulphate * Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation * fail to tracheal intubation at first trial * reduced kidney function * Diabetes mellitus

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation

Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)

Time frame: Change of post operative sore throat level from 1 to 48 hours after surgery

Secondary Outcomes

The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation

Time frame: Change of post operative sore throat level from 1 to 48 hours after surgery

Data from ClinicalTrials.gov

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